BES - BREATH EXPOSURE SYNCHRONIZER— 510(k) K942581

Name: FDA 510(k) clearance K942581
Creator: U.S. Food and Drug Administration
Published: 1994-12-12

Substantially Equivalent

The Henry G. Dietz Co., Inc.

FDA 510(k) clearance K942581 for BES - BREATH EXPOSURE SYNCHRONIZER, Substantially Equivalent on 1994-12-12. Applicant: The Henry G. Dietz Co., Inc.. Device class: 2.

Clearance details

Applicant: The Henry G. Dietz Co., Inc.
Product code: Code KPR
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 1994-05-31
Decision date: 1994-12-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Long Island City, NY, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KPR

product code KPR

Other: 6
Total: 6

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.